1. Field
This disclosure is concerned generally with blood bag systems and specifically with a blood bag system that includes means for assuring that blood or blood components are free of infectious viruses.
2. Prior Art
Plastic bag systems for collecting, processing and storing blood or, more recently, blood components, are well known. Such systems include both single bags and multiple blood bags in sterile communication with each other via tubings and valving systems. Such single and multiple blood bag systems are known as "closed" systems since they permit the collection, processing, storing and administration of blood, blood components or other materials with minimal chance of contamination of the bag contents after blood has been collected from a donor.
The administration of blood and blood components (i.e. red blood cells, platelets and various plasma fractions such as albumin, immunoglobulins, coagulation factors and the like) may pose the risk of transmitting viruses such as hepatitis or HIV from a blood donor to a recipient of the blood or blood component. Although such risk can be minimized by testing all donor blood, it would be very desirable to have in place some back up viricidal system for all blood and blood components intended for transfusion to a recipient other than the donor.
To date, we are aware of only one system where an anti-microbial agent is intentionally included in a closed blood bag system. In U.S. Ser. No. 944,061 filed on Dec. 22, 1986, in the names of A. Champion and M. Collins, there is disclosed a blood bag system which includes a well known anti-microbial known as ciprofloxacin. In that disclosure, however, the anti-microbial agent is already present in the closed system. This can be a disadvantage when it is desirable to keep the anti-microbial separate from the bag contents until needed or if blood bag manufacturing operations call for conditions (i.e. sterilization) that might be detrimental to the anti-microbial. In addition, the disclosed system does not contemplate use of substances that may be unstable with time or substances which are effective only if generated in situ and immediately used.
Although various viricidal agents such as ClO.sub.2 are well known (see U.S. Pat. No. 4,084,747 describing the use of ClO.sub.2 for sanitizing and disinfecting) and the use of ClO.sub.2 is known for AIDS virus inactivation (see New England J. of Med. 313:1416, 1986), we are unaware of the use or generation of such viricidal agents in a closed blood bag system. Further, although the catalytic effect of chloride on chlorine dioxide generation has been disclosed by Kieffer et al. in Inorg. Chem. 7:235 and 239, 1968, we are unaware of the use of that observation for blood bag viricidal applications.
Surprisingly, we have now found a novel system and method for assuring viricidal activity of blood components alone or, preferably, in a closed blood bag system. Details of our discovery are described below.